HyperalgesiaPhase 3CARDIODOLALNCT00802048
Local Anesthetic Infusion and Sternotomy
A Phase 3 study testing Local anesthetic (Ropivacaine) and Saline in people with Hyperalgesia and Pain, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hyperalgesia, Pain
- What is being tested?
- Local anesthetic (Ropivacaine) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 50 to 75 years old
- ASA score : 1-3
- Cardiac surgery with median sternotomy for:
- single valve replacement, Bentall, Bahnson, Tyrone David procedure
- single or multiple Cardiac Artery Bypass Grafting (CABG)
- combined surgery (valve replacement + CABG)
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- without predicted risk of postoperative complication
- Informed consent obtained from the patient
- Patient beneficiating of social insurance
Who cannot join
- patient refusal to participate in the study
- Drug or alcohol abuse history
- Analgesic or opioid consumption within the 12 hours preceding the surgery
- Chronic use of analgesic drugs or history of chronic pain
- Disability to understand morphine PCA use
- Allergy to ropivacaine or other local anaesthesia
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- Patient treated by fluvoxamine or enoxamine
- Patient suffering for liver insufficiency (child score >A)
- Patient with major preoperative hypovolemia
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan
Pessac, 33604
About this study
Official title: Study of Effectiveness of a Ropivacaïne Continuous Sternal Infusion to Reduce Postoperative Hyperalgesia Induced by Sternotomy After Cardiac Surgery
Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion compared with a saline serum infusion to limit postoperative HA, pain and morphine consumption (M) after sternotomy in cardiac surgery.
This strategy could lead to lower postoperative morphine consumption and opioïd induced hyperalgesia.
Read the detailed description
- Principal Objective: comparison of peri-incisionnal dynamic hyperalgesia extend evaluated by Von Frey filament during the first postoperative week between the two groups.
- Secondary Objective: comparison of peri-incisionnal static hyperalgesia (pain threshold) extend evaluated by Von Frey filament, postoperative pain scores, morphine consumption, hemodynamic and respiratory parameters during the first postoperative week and incidence of chronic pain and dysesthesia at six month between the two groups. Ropivacaïne plasmatic concentration will be monitored, during infusion.
- Study design : monocentric, double blind randomized clinical trial comparing two groups of patients with a same intraoperative anesthetic management :
- Group 1: Ropivacaïne infiltration before skin incision followed by a 48 hours Ropivacaïne continuous infusion after surgery through a sternal fenestrated catheter
- Group 2: same protocol with pre and postoperative saline infusion
Postoperative pain management is identical in the two groups based upon a Morphine sulfate PCA pump for the first 48 hours.
- Number of subjects : 40 patients, 20 in each group
- Conditions
- Hyperalgesia, Pain
- Being tested
- Local anesthetic (Ropivacaine), Saline
- Keywords
- Sternotomy, Postoperative hyperalgesia, Intralesional anesthetic infusion, Ropivacaïne, Chronic, Postoperative pain, Cardiac surgery, Sternum, Cardiac surgical procedures
- Medical subject headings
- Hyperalgesia, Pain, Bronchiolitis Obliterans Syndrome, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic (Ropivacaine)Drug
Local anesthetic infusion
SalineDrug
Saline serum infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 48h postoperative infusion of ropivacaine Receives: Drug: Local anesthetic (Ropivacaine) |
| 2 | Placebo comparator | 48h postoperative infusion of NaCl. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperalgesia area size around the cicatrix
Measured: 24h after surgery
Secondary outcomes (4)
Peroperative monitoring datas
Measured: Peroperative
Dynamic hyperalgesia
Measured: Day 2, 3 and 6
Static hyperalgesia
Measured: Day 1, 2, 3 and 6
Ropivacaine plasmatic concentration
Measured: 24h and 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier POUQUET, Dr, Principal investigator, University Hospital, BordeauxAntoine BENARD, Dr, Study chair, University Hospital, BordeauxMathieu LAFARGUE, MD, Principal investigator, University Hospital, BordeauxAlexandre OUATTARA, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802048
- Sponsor's protocol ID
- CHUBX2007/26
- Acronym
- CARDIODOLAL
- Status last verified
- Dec 2011
- First submitted
- 3 Dec 2008
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effectiveness of a Ropivacaïne Continuous Sternal Infusion to Reduce Postoperative Hyperalgesia Induced by Sternotomy After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00802048
- Acronym / sponsor ID
- CARDIODOLAL / CHUBX2007/26
- Conditions
- Hyperalgesia, Pain
- Keywords
- Sternotomy, Postoperative hyperalgesia, Intralesional anesthetic infusion, Ropivacaïne, Chronic, Postoperative pain, Cardiac surgery, Sternum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion compared with a saline serum infusion to limit postoperative HA, pain and morphine consumption (M) after sternotomy in cardiac surgery.
This strategy could lead to lower postoperative morphine consumption and opioïd induced hyperalgesia.
Detailed description
- Principal Objective: comparison of peri-incisionnal dynamic hyperalgesia extend evaluated by Von Frey filament during the first postoperative week between the two groups.
- Secondary Objective: comparison of peri-incisionnal static hyperalgesia (pain threshold) extend evaluated by Von Frey filament, postoperative pain scores, morphine consumption, hemodynamic and respiratory parameters during the first postoperative week and incidence of chronic pain and dysesthesia at six month between the two groups. Ropivacaïne plasmatic concentration will be monitored, during infusion.
- Study design : monocentric, double blind randomized clinical trial comparing two groups of patients with a same intraoperative anesthetic management :
- Group 1: Ropivacaïne infiltration before skin incision followed by a 48 hours Ropivacaïne continuous infusion after surgery through a sternal fenestrated catheter
- Group 2: same protocol with pre and postoperative saline infusion
Postoperative pain management is identical in the two groups based upon a Morphine sulfate PCA pump for the first 48 hours.
- Number of subjects : 40 patients, 20 in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Local anesthetic (Ropivacaine)48h postoperative infusion of ropivacaine |
| 2 | Placebo comparator | Drug: Saline48h postoperative infusion of NaCl. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged from 50 to 75 years old
- ASA score : 1-3
- Cardiac surgery with median sternotomy for:
- Informed consent obtained from the patient
- Patient beneficiating of social insurance
Key exclusion criteria (9 listed)
- patient refusal to participate in the study
- Drug or alcohol abuse history
- Analgesic or opioid consumption within the 12 hours preceding the surgery
- Chronic use of analgesic drugs or history of chronic pain
- Disability to understand morphine PCA use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthetic (Ropivacaine)Local anesthetic infusion | Drug | 1 |
| SalineSaline serum infusion | Drug | 2 |
Primary outcome
hyperalgesia area size around the cicatrix
Time frame: 24h after surgery
4 secondary outcomes
Peroperative monitoring datas
Time frame: Peroperative
Dynamic hyperalgesia
Time frame: Day 2, 3 and 6
Static hyperalgesia
Time frame: Day 1, 2, 3 and 6
Ropivacaine plasmatic concentration
Time frame: 24h and 48h
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier POUQUET, Dr principal investigator
University Hospital, Bordeaux
Antoine BENARD, Dr study chair
University Hospital, Bordeaux
Mathieu LAFARGUE, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Local anesthetic (Ropivacaine) and Saline in people with Hyperalgesia and Pain, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyperalgesia area size around the cicatrix (time frame: 24h after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.